Gamunex gains neurologic disease indication
The FDA has approved Gamunex (IV immune globulin [human], from Talecris Biotherapeutics) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
In clinical trials, Gamunex was effective at improving certain motor tasks, as measured by the Inflammatory Neuropathy Cause and Treatment scale (INCAT) for ≤48 weeks of treatment. In a 24-week follow-up trial, 86% of the patients from the previous trial maintained their improved INCAT scores compared to 61% of the patients who received placebo.
Gamunex is already approved for the treatment of idiopathic thombocytopenic purpura (ITP).
For more information call (800) 520-2807 or visit www.gamunex.com.